METHODS: We conducted a systematic review of 17 national and international clinical trial databases for all disease-modifying anti-rheumatic drugs (DMARDs) for PMR and GCA that are already marketed, in clinical development or withdrawn. The search was performed on January 2024, with the keywords \"polymyalgia rheumatica\" and \"giant cell arteritis\". For each molecule, we only considered the study at the most advanced stage of clinical development.
RESULTS: For PMR, a total of 15 DMARDs were identified: 2 conventional synthetic DMARDs (csDMARDs), 11 biologic DMARDs (bDMARDs) and 2 targeted synthetic DMARDs (tsDMARDs). For GCA, 18 DMARDs were identified: 2 csDMARDs, 14 bDMARDs and 2 tsDMARDs. Currently, there are only 2 approved corticosteroid-sparing therapies in these diseases, which both target the IL-6 signaling pathway, namely tocilizumab in GCA and sarilumab in PMR. Most of the molecules in current development are repurposed from from other conditions and clinical research in PMR/GCA seems to be mostly driven by the potential to repurpose existing treatments rather than by translational research.
CONCLUSIONS: This systematic review identified 23 DMARDs evaluated for PMR and GCA: 3 csDMARDs, 17 bDMARDs and 3 tsDMARDs. Several promising treatments are likely to be marketed in the coming years.
方法:我们对已经上市的用于PMR和GCA的所有疾病改善抗风湿药(DMARDs)的17个国家和国际临床试验数据库进行了系统评价,在临床开发或退出。搜索于2024年1月进行,关键字为“风湿性多肌痛”和“巨细胞动脉炎”。对于每个分子,我们只认为这项研究处于临床发展的最晚期.
结果:对于PMR,总共鉴定了15种DMARDs:2种常规合成DMARDs(csDMARDs),11个生物DMARDs(bDMARDs)和2个靶向合成DMARDs(tsDMARDs)。对于GCA,确定了18个DMARD:2个csDMARD,14个bDMARDs和2个tsDMARDs。目前,在这些疾病中只有两种批准的保留皮质类固醇的疗法,两者都靶向IL-6信号通路,即GCA中的托珠单抗和PMR中的sarilumab。当前开发中的大多数分子都是从其他条件中重新利用的,PMR/GCA的临床研究似乎主要是由重新利用现有治疗的潜力而不是转化研究驱动的。
结论:本系统评价确定了23个对PMR和GCA进行评估的DMARDs:3个csDMARDs,17个bDMARDs和3个tsDMARDs。几种有希望的治疗方法可能会在未来几年内上市。